Incretin-based therapy in non-symptomatic, early diagnosed type 1 diabetics

Conditions: Type 1 diabetes
MedDRA version: 18.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2014-004760-37-FI

Lead Sponsor: Riitta Veijola

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 10

Inclusion Criteria

The subjects are 10-30 years of age, have early diagnosis type 1 diabetes (no symptoms, diagnosis usually in OGTT), and are not pregnant.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Principal exclusion criteria are:
• previous treatment in the last three months with any antidiabetic medication other than insulin
• impaired liver or kidney function
• past or current history of pancreatitis
• serum calcitonin value above normal (>50 ng/l)
• presence of any chronic metabolic, hematologic or malignant disease
• obesity BMI =30
• pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of the trial is to study whether daily treatment with liraglutide improves insulin secretion and reduces the requirement of exogenous insulin, and whether liraglutide treatment is tolerable and safe in subjects aged 10-30 years, having an early diagnosis of type 1 diabetes (no symptoms, diagnosis usually in OGTT), and treated with insulin.;Secondary Objective: In addition, the effect of daily liraglutide treatment on immunological variables and blood glucose control will be studied.<br>;Primary end point(s): Primary end point (1) is:<br>1) serum C-peptide area under the curve (AUC) during 2-hour MMTT (mixed meal tolerance test);Timepoint(s) of evaluation of this end point: Timepoints for evaluation of primary end point (1) are:<br>1) 1 week before start of treatment and 3, 6, 9 and 12 months after start of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end points (1-5) are:<br>1) insulin dose IU/kg/day<br>2) plasma glucose variability during continuous glucose monitoring (CGM)<br>3) HbA1c<br>4) safety: serum and urine amylase, serum lipase, serum calcitonin, hypoglycemia<br>5) tolerability: frequency of gastrointestinal side effects (diarrhea, nausea, vomiting);Timepoint(s) of evaluation of this end point: Timepoints for evaluation of secondary end points (1-5) are:<br>1) 1 wk before start of treatment, at the start of treatment, and then at 1, 2, 3, 4, 5, 6 wk and 3, 4, 5, 6 mo, 6 mo + 1 wk, 7, 8, 9, 10, 11, 12 mo and 12 mo + 1 wk after start of treatment<br>2) 1 wk before start of treatment, and 3, 6, 9 and 12 mo after start of treatment<br>3) 1 wk before start of treatment, and 6 wk, 3, 6, 9 and 12 mo after start of treatment<br>4) 1 wk before start of treatment, and 6 wk, 3 , 6 , 9 and 12 mo after start of treatment<br>5) 1, 2, 3, 4, 5, 6 wk and 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 mo after start of treatment